Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy

NCT ID: NCT06993922

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-29

Study Completion Date

2025-11-01

Brief Summary

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This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.

Detailed Description

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Scalp block is proposed as a multimodal approach to preventing postoperative pain and hemodynamic responses to previous noxious stimulation during the operation.

The use of adjuvants, such as dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, has recently been studied for its analgesic effects. Dexmedetomidine acts additionally to local anesthetics, prolonging their duration of action.

Conditions

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Dexmedetomidine Adjuvant Bupivacaine Scalp Block Postoperative Pain Craniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group SB

Patients will receive a scalp block with bupivacaine alone.

Group Type ACTIVE_COMPARATOR

Scalp block

Intervention Type OTHER

Patients will receive a scalp block with bupivacaine alone.

Group SD

Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.

Group Type EXPERIMENTAL

Scalp block + Dexmedetomidine

Intervention Type OTHER

Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.

Interventions

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Scalp block

Patients will receive a scalp block with bupivacaine alone.

Intervention Type OTHER

Scalp block + Dexmedetomidine

Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.

Intervention Type OTHER

Other Intervention Names

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Bupivacaine Bupivacaine + Dexmedetomidine

Eligibility Criteria

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Inclusion Criteria

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I or II.
* Undergoing supratentorial elective planned craniotomies.

Exclusion Criteria

* Patients refusal.
* History of known allergy to the used local anesthetic or dexmedetomidine.
* Bleeding disorders.
* Evidence of local infection at the site of injection.
* Emergency craniotomy.
* Psychotic disorder.
* Patients who will not be extubated in the operating room after surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Omar Ahmed Zakaria Khiralla

Resident of Anaesthesia, Intensive Care Unit and Pain, Faculty of Medicine, Ain shams University, Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Omar A Khiralla, MBBCH

Role: CONTACT

00201095281838

Facility Contacts

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Omar A Khiralla, Master

Role: primary

00201095281838

Other Identifiers

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FMASU MS 57/2025

Identifier Type: -

Identifier Source: org_study_id

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